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Phase III Investigational Trial of NUBEQA® in Combination with Docetaxel and Androgen Deprivation Therapy Increases Overall Survival in Patients with mHSPC
AmericanPharmaceuticalReview
December 06, 2021
The Phase III ARASENS trial investigating the use of the oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary endpoint. In the ARASENS trial, NUBEQA in combination...
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Janssen’s Erleada maintains quality of life for prostate cancer patients
pharmatimes
May 27, 2021
Janssen’s Erleada in addition to androgen deprivation therapy (ADT) maintained prostate cancer patients’ health-related quality of life (HRQoL), according to new patient-reported outcomes (PRO) data.
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NICE turns down Janssen's Erleada
pharmatimes
May 21, 2021
The National Institute for Health and Care Excellence (NICE) has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy (ADT) for treating prostate cancer.
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NICE sticks to Zytiga rejection
pharmatimes
June 29, 2020
NICE will not be recommending Janssen's Zytiga (abiraterone acetate) with prednisone or prednisolone plus androgen deprivation therapy (ADT), within its marketing authorisation , for treating newly diagnosed high-risk metastatic ...
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Comorbid CVD May Up Mortality With ADT for Prostate Cancer
drugs
August 14, 2019
Elderly prostate cancer patients with preexisting cardiovascular diseases (CVDs) using abiraterone acetate (AA) or enzalutamide (ENZ) have higher short-term mortality compared with their counterparts without CVDs...
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Bayer files prostate cancer drug darolutamide in Japan
pharmaphorum
March 07, 2019
Bayer has filed its prostate cancer drug darolutamide with Japanese regulators, in an attempt to ratchet up the pressure on rivals Johnson & Johnson and Pfizer/Astellas.
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Orion and Bayer seek marketing clearance for darolutamide in Japan
pharmaceutical-technology
March 06, 2019
Orion and Bayer have submitted an application to the Japanese Ministry of Health, Labor and Welfare (MHLW) seeking marketing authorisation for darolutamide to be applied in the treatment castration-resistant prostate cancer (CRPC).